Career Connections Canada Inc.
'Connecting great people with great companies"
REMOTE: Partial, until end of pandemic
Join a rapidly expanding, successful Canadian Biologics developer and manufacturer. Our client supplies the international clinical diagnostic marketplace with biological drugs and Dx testing products, promoting and enhancing human health.
As a QA Quality Assurance Manager, you will responsible for all QA processes – e.g. risk management, ISO, QMS, design control, process validation, metrics, audits.
ROLE AND RESPONSIBILITIES:
- Meet requirements for site R&D GMP compliance.
- Work with company QMS, ensuring it meets current ISO 13485 and 9001 standards, as it transitions to the Cloud.
- Process validation.
- Non-conformance investigations, risk management, CAPA.
- Manage customer quality agreements and other quality requirements.
- Compliance SME, audit representative.
- Vendor management.
- BS / MS Life Sciences.
- CQA nice to have.
- Min 7 years in QA within life sciences, min 3 as QA Manager.
- Background working with QMS.
- Knowledge of GMP, ISO, FDA, Health Canada, EU requirements and standards.
- Project management and risk management skills.
- CAPA, SOPs, non-conformance, remediation, audit, validation background.
- Excellent people, computer, and project management skills.
***Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections